|Amarin soars on Phase III results. Angiotech flys on supply agreement. AMAG gets positive FDA label|
|By BioMedReports.com Staff|
|Monday, 29 November 2010 19:37|
As reported earlier today on BioMedReports, Amarin Corporation plc (Nasdaq:AMRN), reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides, met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company's rights to this product through 2030.
Shares soared $2.30 or 65% to close heavy trading at $5.85. Nearly 44 million shares exchanged hands today.
Shares of Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPI) soared today after the company announced that it has entered into a private label product supply agreement with Hologic, Inc. (NASDAQ:HOLX) for soft tissue biopsy instruments manufactured by Angiotech. The initial term of the supply agreement is for three years with automatic renewals for additional periods of three years each. The agreement is specific to products sold in the United States for use in breast biopsies.
In 2009, there were approximately 1.8 million breast biopsies performed in the U.S. The U.S. minimally invasive breast biopsy systems market, which includes vacuum-assisted breast biopsy hand pieces, consoles, and accessories/disposables as well as tissue markers and stereotactic biopsy tables, is estimated at $427M in 2008 according to Elsevier Business Intelligence's Medtech Insight market intelligence reports.
Heavy volume pushed shares of Angiotech up 9 cents or 50% to $.2756.
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG), today announced that the company has reached an agreement with the FDA regarding an update to the product label for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.
Essentially, the FDA did not apply a "black box" warning label on its drug to treat iron deficiency anemia in adult patients with chronic kidney disease. Reports of life threatening hypersensitivity have put Feraheme under the microscope with the FDA.
The new label will include bolded warnings and precautions that describe the adverse events that have been reported after administration of the drug. The label will also provide instructions to health care providers to increase the observation period following Feraheme administration from 30 to 60 minutes for observation of symptoms of hypersensitivity.
Nearly 3 million shares traded Monday propelling the stock to $15.91, up $1.86 or 13.24%.
Theravance, Inc. (NASDAQ:THRX) announced today that GlaxoSmithKline plc (NYSE: GSK) will increase its shareholding in Theravance by purchasing 5.7 million shares of Theravance common stock in a private placement at $22.50 per share. The total investment exceeds $129 million. Following this purchase, GSK will own 15,151,499 shares of Theravance common stock and Class A common stock, which represent approximately 19% of the total outstanding capital stock of Theravance.
Theravance jumped $2.35, more than 10% to close Monday trading at $25.20.
After the bell Monday, Clinical Data, Inc (NASDAQ: CLDA) announced that it has signed a definitive asset purchase agreement with Transgenomic, Inc. (OTCBB:TBIO.ob) to sell it’s genetic and pharmacogenomic testing and biomarker development business for approximately $15.4 million. Clinical Data will receive a percentage of accounts receivables collected by Transgenomic after the closing, as well as milestones and royalty payments on the anticipated development and commercialization of multiple new pharmacogenomic diagnostic products. The transaction will complete Clinical Data’s transformation to a pharmaceutical company with a deep product pipeline including two late-stage compounds, the most advanced of which is vilazodone, a new treatment in development for Major Depressive Disorder, followed by Stedivaze, a coronary vasodilator in Phase III development for myocardial perfusion imaging.
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE, 4502), today announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.
"Our plan is to pursue approval of peginesatide for the treatment of anemia in CRF patients on dialysis," said Arlene M. Morris, chief executive officer of Affymax. "Based on our meeting with FDA, we believe the data from our completed trials are sufficient for review of our NDA for this indication. Our goal is to submit the NDA for peginesatide for the treatment of anemia in chronic renal failure patients on dialysis in the second quarter of 2011."
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that updated clinical data from a fully enrolled Phase 1 trial of its investigational, pan-BCR-ABL inhibitor, ponatinib, will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) being held in Orlando, Florida, December 4-7, 2010. These Phase 1 findings in patients with resistant and refractory chronic myeloid leukemia (CML) will be featured in an oral presentation and will also be highlighted in a webcast investor meeting being held at ASH.
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX, TASE: PLX) today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010. On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel.
Taliglucerase alfa was granted orphan drug designation by the U.S. Food and Drug Administration. A New Drug Application for taliglucerase alfa has been accepted by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011. Taliglucerase alfa is available to patients with Gaucher disease in the United States under an Expanded Access protocol as well as to patients in several member states of the European Union, Israel and other countries under Named Patient provisions.
Spectrum Pharmaceuticals (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
The FDA considers the submission a Class 2 response, therefore, the PDUFA Action Date is April 29, 2011.
FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent over-dosage of folic acid antagonists.
The Medicines Company (NASDAQ:MDCO) today announced that it has received notification from the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, that the design and planned analysis of Phase 3 clinical trials for oritavancin in patients with acute bacterial skin and skin structure infection (ABSSSI) adequately address the objectives necessary to support a regulatory submission.
With the SPA agreement in place, the Company plans to start the identical "SOLO-1" and "SOLO-2" clinical trials to evaluate the efficacy and safety of single-dose oritavancin as compared to multiple doses of vancomycin for the treatment of patients with ABSSSI.
Medivation, Inc. (Nasdaq:MDVN) and Astellas Pharma Inc. today announced that patient enrollment was completed on November 15, 2010 in the Phase 3 AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy. The companies also announced that clinical development of MDV3100 in Japan has commenced, with the initiation of patient dosing in a Phase 1-2 clinical study.
"There has been a lot of positive news for advanced prostate cancer patients over this past year, and the completion of patient enrollment in AFFIRM is yet another significant achievement in the development of new therapies to treat this devastating disease," said Lynn Seely, M.D., chief medical officer of Medivation.
Zalicus Inc. (NASDAQ:ZLCS) announced today that preclinical data on its discovery of novel A2A agonist oncology programs for the treatment of multiple myeloma and other B-cell malignancies will be highlighted at the 52nd Annual Meeting of the American Society of Hematology in Orlando, FL on December 4-7, 2010
3SBio Inc. (Nasdaq:SSRX) a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that is has acquired worldwide rights of pegsiticase for all indications from EnzymeRx for a total consideration of US$6.25 million.